Nitrofurantoin Related Compounds & Impurities

Nitrofurantoin is a nitrofuran antibiotic with urinary tract-specific activity, used for uncomplicated lower urinary tract infections and prophylaxis.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Nitrofurantoin reference standards, pharmacopeial and non-pharmacopeial Nitrofurantoin impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Nitrofurantoin-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Nitrofurantoin
Nitrofurantoin Related compound A
Nitrofurantoin Impurity 1
Nitrofurantoin Impurity 3
3-Aminohydantoin
Nifuratel Impurity 3
3-Aminohydantoic Acid
2-Hydrazinylacetic Acid
Nitrofuraldehyde Diacetate Propionate
2,5-dioxo-3-(propan-2-ylideneamino)imidazolidine-1-carboxamide
Nitrofurantoin Monohydrate
1-[(2-furanylmethylene) amino]- 2,4-Imidazolinedione
N-Nitroso Nitrofurantoin
Nitrofurantoin Nitroso Impurity 1
Nitrofurantoin Impurity 5
Nitrofurantoin Impurity 6
Nitrofurantoin Impurity 7
Nitrofurantoin Impurity 4
Nitrofurantoin Impurity 2
Nitrofurantoin Impurity 9
Nitrofurantoin Impurity 10
N-Nitroso impurity 1
Nitrofurantoin Impurity 12
Nitrofurantoin Impurity 8

Metabolites

2-[-2[(5-Nitro-2-furanyl)methylene]hydrazinyl]acetic Acid
Aminofurantoin

Isotope Labelled Compounds

Nitrofurantoin -13C3